tbuckley/cabot-search huggingface dataset:
Systematic review of real-world evidence studies in women’s cancer at key congresses and factors related to high tier acceptance.
Authors: Elizabeth A. Szamreta, Mansi Modi, Ramu Periyasamy, Bhavani Yamsani, Sumedha Kulkarni, Matthew J. Monberg
Journal: Journal of Clinical Oncology (2022)

e17533 Background: Real-world evidence (RWE) studies complement clinical trials (CT) and address a variety of issues, such as adherence, cost, comparative effectiveness, and treatment patterns. This systematic review assessed prevalence and characteristics of RWE presented at oncology congresses. Methods: Data on women’s cancers (cervical, ovarian, endometrial, and multiple [gyn/other]) work were extracted from the databases of American Society of Clinical Oncology (ASCO) and The Society of Gynecological Oncology (SGO) congresses (2018-2020). The primary objective was to identify the proportion of CT vs RWE. Secondary objectives were to: a) describe the tier of acceptance for RWE vs CTs; b) describe prevalence of types of RWE; c) analyze the characteristics (data source, design, authorship, outcome(s) assessed, and presence of statistically significant results) associated with RWE acceptance. Results: Of 3163 abstracts screened, 2271 were included (1756 RWE vs 515 CTs). RWE represented a higher proportion of work at SGO vs ASCO (90% vs 59%). Overall, more RWE vs CTs was accepted as a poster (75% vs 60%) or publication only (19% vs 11%), while less was accepted for oral presentation (4% vs 20%). Among RWE, 90% had academic author(s), 44% used clinical data, around one quarter used another data repository/registry, and about 14% used medical record or chart review data. Nearly two thirds of RWE studies reported significant results, while 6% contained no significant results. There was no clear association between authorship or significance of results and tier of acceptance. About 60% of RWE studies were retrospective, 9% were prospective, 4% focused primarily on PROs, and 2% were economic models. The most common outcomes assessed in RWE studies were molecular analyses (18%) and survival based on treatment efficacy (13%). Among molecular analyses, most (68%) were accepted as a poster, with 26% accepted as publication only and 4% as oral. An even greater fraction (77%) of survival/efficacy analyses were accepted as a poster, 18% as publication only and even fewer (2%) as oral. Conclusions: RWE was more frequently presented than CTs at both ASCO and SGO. However, across congresses and cancer types, a smaller proportion of RWE vs CT work was accepted as an oral presentation. Results indicated high interest in CTs; RWE studies utilizing clinical data or data repository/registry data, and those with molecular and/or survival outcomes, were most common. The results demonstrate that while RWE studies are prevalent and provide valuable data for healthcare decision-making, they do not always achieve the visibility of CTs.[Table: see text]
RONC-03. Secondary Neoplasms in Children with Central Nervous System (CNS) Tumors Following Radiotherapy in the Modern Era
Authors: Daniel Indelicato, Kathryn Tringale, Julie Bradley, Raymond Mailhot Vega, Christopher Morris, Dana Casey, Suzanne Wolden
Journal: Neuro-Oncology (2022)

Abstract PURPOSE: To assess reduction of secondary radiation-induced neoplasms over the past two decades, focusing on children with CNS tumors who received intensity modulated radiotherapy (IMRT) or proton therapy (PT). METHODS: A total of 1044 children received radiotherapy for a primary CNS tumor at 2 institutions between 1999 and 2020, including 99 treated with IMRT and 945 treated with PT. Median age was 8.7 years old. Median follow-up was 6.0 years and included 83 and 510 patients with &amp;gt;5 years follow-up in the IMRT and proton cohorts, respectively. Cumulative incidence method provided estimates of secondary neoplasms encompassing benign and malignant solid tumors as well as leukemia. Multiple variables were assessed using proportional hazard regression for competing risks. RESULTS: Ten-year overall survival was 87.4%. Patients treated with IMRT were significantly older, with a median age of 10.4 vs 8.4 years old (p &amp;lt;0.001), but were more likely to receive craniospinal irradiation (31.3% vs 14.2%, p &amp;lt;0.001) or alkylating chemotherapy (50.5% vs 29.7%, p &amp;lt;0.001). The 5- and 10-year cumulative incidence of second neoplasm was 0.7% and 2.3%, respectively. On multivariate analysis, age &amp;lt;5 (4.9% vs 0.7% at 10 years) and tumor predisposition syndrome (34.3% vs 1.5% at 10 years) were significantly associated with a second neoplasm (p &amp;lt; 0.01 for each). On both univariate and multivariate analyses, PT was not associated with a lower incidence of second neoplasm. Following IMRT, 1/2 second solid tumors occurred outside the target volume, compared to 2/11 after PT. CONCLUSION: Following modern radiotherapy, approximately 2% of children with a CNS tumor will develop a second neoplasm within 10 years of treatment. Compared to IMRT, PT was not associated with an overall reduction in second neoplasms. More events and follow-up beyond 10 years are needed to determine if proton therapy reduces the incidence of second solid tumors occurring specifically in the low dose region.
PKUCH 04 trial: Total neoadjuvant chemoradiation combined with neoadjuvant PD-1 blockade for pMMR/MSS locally advanced middle to low rectal cancer.
Authors: Aiwen WU, Yingjie Li, Dengbo Ji, Li Zhang, Xiaoyan Zhang, Yong Cai, Yangzi Zhang, Yunfeng Yao, Lin Wang, Jiahua Leng, Tiancheng Zhan, Ying-Shi Sun, Zhongwu Li
Journal: Journal of Clinical Oncology (2022)

3609 Background: Total neoadjuvant therapy (TNT) with induction chemotherapy and chemoradiation is the standard of care for locally advanced rectal cancers. Incorporation of PD-1 blockade in the neoadjuvant setting is promising for mismatch repair deficient (dMMR) patients, yet the efficacy of TNT combined with PD-1 blockage for pMMR/MSS patients is little unknown. The purpose of this study is to evaluate the clinical benefit of neoadjuvant PD-1 blockade combined with TNT in pMMR/MSS locally advanced rectal cancer. Methods: We designed a prospective, single-arm, phase II study on locally advanced dMMR/MSS rectal cancer (PKUCH 04 trial). Patients will receiving neoadjuvant regimen (PD-1 inhibitor, camrelizumab, also called SHR01210, 200mg d1, oxaliplatin 130mg/m2 d1, capecitabine 1250mg/m2 bid1-14, for three cycles, then long course chemoradiation (IMRT, 1.8Gy/f*25f), then another two cycles of CapeOx (oxaliplatin 130mg/m2 d1, capecitabine 1250mg/m2 bid1-14, q3wks) if no disease progression occurs. The primary endpoint was pathologic complete response (pCR) rate, and the secondary outcome include adverse event and surgical complication. Tumor assessment was carried out after induction, chemoradiation, and before the decision of either surgery or watch and wait. Results: A total of 27 patients were screened and finally 25 patients were eligible for further analysis, with median age 58 years (range 31-70). The median distance from the anal verge was 5.3 cm (1.2-10). 76% were male, 76% had N2 disease, 56% positive MRF, 80% positive EMVI. All patients have completed the induction and chemoradiation phases. 21 patients underwent TME surgery, of which 7 had pathological complete response (33.3%). Four achieved clinical complete or near complete response and chose watch and wait. 7 had major pathological remission (over 90% remission). Another 7 had partial pathological remission. No progressive disease was found. 14 had LAR, 7 APR, and. The surgical complication rate was 14.3%, and the mortality rate was 0. The common adverse events included nausea (80%), lymphopenia (80%), paresthesia (76%), reactive cutaneous capillary endothelial proliferation (72%), neutropenia (68%). Grade 3 adverse events include lymphopenia (24%), diarrhea (8%), and thrombocytopenia (4%) and no grade 4 or 5 events were observed. Till January 2022, no recurrence or regrowth was found. Conclusions: Total neoadjuvant chemoradiation combined with neoadjuvant PD-1 blockade is safe and effective which can achieve good regression and sphincter preservation for pMMR/MSS rectal cancer. This suggests a potential new paradigm for treatment of pMMR/MSS locally advanced rectal cancer and necessitates further investigation. Clinical trial information: NCT04340401.
Preliminary results of raltitrexed in Chinese patients with metastatic colorectal cancer: A prospective, multicenter, real-world study.
Authors: Jin Li, Shukui Qin, Ai-Ping Zhou, Yanqiao Zhang, Xianglin Yuan, Baoli Qin, Shan Zeng, Lin Shen, Ying Yuan, Liangjun Zhu, Weibo Wang, Xianwen Zhang, Jun Liang, Feng Ye, Ping Chen, Huaizhang Wang, Zhengyan Yu, Yong Fang, Lu Yue, Jianping Xiong
Journal: Journal of Clinical Oncology (2022)

3591 Background: Raltitrexed-based chemotherapy regimen is one of the common regimens for the treatment of metastatic colorectal cancer (mCRC). This prospective observational real-world study aimed to evaluate the safety and effectiveness of raltitrexed administered to Chinese patients with mCRC in real life setting. Methods: This is a prospective, multicenter, real-world study. Prospectively registered Patients received second-line treatment of raltitrexed plus irinotecan combined with or without target therapy until progression disease or unacceptable toxicity. The primary endpoint was progression-free survival (PFS), and the secondary endpoints were objective response rate (ORR), disease control rate (DCR), overall survival (OS), quality of life (QOL) and safety. Totally,1000 patients were required for primary point testing. Results: Between May 2018 and December 2021,a total of 1039 patients from 57 centers were screened for enrollment,among which 271 patients were treated with raltitrexed plus irinotecan, 753 patients accepted target therapy (bevacizumab or cetuximab) additionally, and 15 patients combined with other drugs. Overall mPFS was 6.8 months (95%CI: 6.5-7.1),ORR was 20.2%, and DCR was 85.7%; The ORR of combined with or without target therapy were 21.6% and 16.2% ( p = 0.038),respectively, the DCR were 88.2% and 79.0% ( p &lt; 0.001). The mPFS of combined without or with target therapy were 5.2 months (95% CI: 4.7 to 5.7) and 7.3 months respectively (95% CI: 7.0-7.7) [HR = 0.67, 95% CI 0.56̃0.80, p &lt; 0.001], The mPFS of combined with bevacizumab or cetuximab were 7.4 months (95% CI: 7.0 -7.8) and 6.8 months (95% CI: 5.9-7.7) [HR = 1.15, 95% CI 0.88̃1.51, p = 0.3]. mOS has not yet reached. Majority of treatment-related adverse events (TEAEs) were grade I or II. The most common grade III or IV TRAEs reported by 116 patients (11.2%) were aspartate aminotransferase increased (4.0%), alanine aminotransferase increased (3.7%), neutrocytopenia (2.7%), glutamyltransferase increased (2.5%), leukocytopenia (1.1%). Conclusions: The real-world study confirmd that raltitrexed was an effective and safe regimen for the second-line treatment in Chinese patients with mCRC, especially combined with target therapy additionally, which was aligned with previous trials. Clinical trial information: ChiCTR1800016185.
Dexmedetomidine vs other sedatives in critically ill mechanically ventilated adults: a systematic review and meta-analysis of randomized trials
Authors: Kimberley Lewis, Fayez Alshamsi, Kallirroi Laiya Carayannopoulos, Anders Granholm, Joshua Piticaru, Zainab Al Duhailib, Dipayan Chaudhuri, Laura Spatafora, Yuhong Yuan, John Centofanti, Jessica Spence, Bram Rochwerg, Dan Perri, Dale M. Needham, Anne Holbrook, John W. Devlin, Osamu Nishida, Kimia Honarmand, Begüm Ergan, Eugenia Khorochkov, Pratik Pandharipande, Mohammed Alshahrani, Tim Karachi, Mark Soth, Yahya Shehabi, Morten Hylander Møller, Waleed Alhazzani
Journal: Intensive Care Medicine (2022)
In patients with COVID-19 at risk for severe disease, nirmatrelvir + ritonavir reduced hospitalization or death
Authors: Athanasios Vassilopoulos, Eleftherios Mylonakis
Journal: Annals of Internal Medicine (2022)

Hammond J, Leister-Tebbe H, Gardner A, et al. Oral nirmatrelvir for high-risk, nonhospitalized adults with Covid-19. N Engl J Med. 2022;386:1397-408. 35172054.
Clinical characteristics and outcomes of COVID-19 disease in patients with cancer.
Authors: Muhammet Ozer, Suleyman Yasin Goksu, Mohammed Mahdi, Neel Jitendra Gandhi
Journal: Journal of Clinical Oncology (2022)

e18678 Background: The Coronavirus Disease 2019 (COVID- 19) has been nominated as a pandemic by the World Health Organization short after has spreaded globally. Unfortunately, even after several effective vaccines approved by FDA, COVID-19 cases are still surging. Compared to the general population, patients with cancer are more susceptible to COVID-19 for many aspects. Therefore, better understanding of the clinical characteristics of cancer patients with COVID-19 is urgently needed to spare these vulnerable patients from severe disease course. Methods: This retrospective study was completed in Capital Health Regional Medical Center, New jersey, USA. Adult patients with COVID-19 diagnosed between March 2020 and May 2021 were included in this study. All selected COVID-19 patients were stratified as two groups: Patients with cancer and patients without cancer. Other variables were included as age at diagnosis, gender, race/ethnicity, insurance status, obesity, comorbidity score, treatment of COVID-19, oxygen requirement and vital status. The Charlson Comorbidity Index was used to calculate the comorbidity score. Results: A total of 562 COVID-19 patients were included in this study; 67 (12%) patients diagnosed with cancer. Patients with cancer were more likely to be older (73 vs. 62 years, p &lt; 0.001), overweight (BMI 25-29.9) (39% vs 28%, p = 0.02), and have higher comorbidity score &gt; 3 (58% vs 15%, p &lt; 0.001) than patients without cancer. Patients with cancer more frequently received steroid therapies (52% vs. 34%, p = 0.003), remdesivir (21% vs. 4%, p &lt; 0.001), and convalescent plasma (21% vs. 10%, p = 0.009). The rate of high flow oxygen therapy was higher in patients with cancer than patients without cancer (30% vs. 16%, p = 0.02). The days of mechanic ventilation, hospital stay, ICU admission were similar between two groups. Patients without cancer had better survival rate compared to patients with cancer (77% vs. 64%, p = 0.02). Patients with cancer had increased D-dimer level (2.4 vs. 1.6 mg/L, p = 0.08) compared to patients without cancer but it was not significantly different. Other laboratory findings were also similar between two groups, including WBC, neutrophils, lymphocytes, lactate, lactate dehydrogenase, creatine kinase, d-dimer, C-reactive protein, procalcitonin, fibrinogen, BNP, troponin, sodium, AST, ALT, and ferritin. Multivariable logistic regression analysis showed that patients with cancer were associated with increased odds of higher than 3 comorbidity score (OR 7.09 [3.85-13.05], p &lt; 0.001) and oxygen therapy with nasal cannula up to 6 liters (OR 3.7 [1.04-13.5], p = 0.04). Conclusions: This present analysis showed that patients had increased risk of mortality compared to counterpart. Our results emphasize that cancer patients as a group are at higher risk due to advanced age and preexisting conditions.
The anti–SARS-CoV-2 monoclonal antibody bamlanivimab minimally affects the endogenous immune response to COVID-19 vaccination
Authors: Robert J. Benschop, Jay L. Tuttle, Lin Zhang, Josh Poorbaugh, Nicole L. Kallewaard, Peter Vaillancourt, Melissa Crisp, Thi Ngoc Vy Trinh, Joshua J. Freitas, Stephanie Beasley, Montanea Daniels, Natalie Haustrup, Richard E. Higgs, Ajay Nirula, Myron S. Cohen, Mary Marovich
Journal: Science Translational Medicine (2022)

As the coronavirus disease 2019 (COVID-19) pandemic evolves and vaccine rollout progresses, the availability and demand for monoclonal antibodies for the prevention and treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection are also accelerating. This longitudinal serological study evaluated the magnitude and potency of the endogenous antibody response to COVID-19 vaccination in participants who first received a COVID-19 monoclonal antibody in a prevention study. Over the course of 6 months, serum samples were collected from a population of nursing home residents and staff enrolled in a clinical trial who were randomized to either bamlanivimab treatment or placebo. In an unplanned component of this trial, a subset of these participants was subsequently fully vaccinated with two doses of either SpikeVax (Moderna) or Comirnaty (BioNTech/Pfizer) COVID-19 mRNA vaccines. This post hoc analysis assessed the immune response to vaccination for 135 participants without prior SARS-CoV-2 infection. Antibody titers and potency were assessed using three assays against SARS-CoV-2 proteins that bamlanivimab does not efficiently bind to, thereby reflecting the endogenous antibody response. All bamlanivimab and placebo recipients mounted a robust immune response to full COVID-19 vaccination, irrespective of age, risk category, and vaccine type with any observed differences of uncertain clinical importance. These findings are pertinent for informing public health policy with results that suggest that the benefit of receiving COVID-19 vaccination at the earliest opportunity outweighs the minimal effect on the endogenous immune response due to prior prophylactic COVID-19 monoclonal antibody infusion.
Baseline characteristics and outcomes of 10.485 prostate cancer patients on delayed palliative management: A report from PIONEER, a big data for better outcome programme
Authors: J. Gómez Rivas, L.Y.H. Lai, C. Chatzichristos, M. Van Hemelrijck, K. Beyer, M. Oja, S. Tamm, S. Reisberg, J. Vilo, A. Asiimwe, C. Steinbeisser, A. Bjartell, V. Sakalis, J. N' Dow
Journal: European Urology (2022)
Assessing breast cancer screening results through the lens of COVID-19 pandemic.
Authors: Dilyara Kaidarova, Alma Zhylkaidarova, Muratzhan Saktaganov
Journal: Journal of Clinical Oncology (2022)

e22507 Background: In January, 2020 World Health Organization (WHO) declared the COVID-19 outbreak as the first global health emergency. Lockdowns and restrictive procedures with the full and partial cancellation of preventive measures, including breast cancer (BC) screening, took place in Kazakhstan in 2020-2021. Purpose of this study: to determine the impact of the COVID-19 pandemic on BC screening results. Methods: The main screening indicators before (2018-2019) and during the COVID-19 pandemic (2020-2021) were studied: planned coverage and number of examined patients, the proportion of BI-RADS categories (where BI-RADS categories 4-5 are accepted as suspicious for malignancy, additional imaging by ultrasound and/or mammography followed biopsy is recommended), the number of detected cancer cases, the stage of the disease according to the screening database and the Electronic Cancer Registry. Results: 1,624,667 women underwent BC screening in 2018-2019 (96.2% of the planned amount of 1,688,829 women). 1,532,591 (79.4%) women were examined in 2020-2021, though the planned amount was 1,930,515. Before the epidemic, 23,296 patients received BI-RADS categories 4-5 (1.43% from examined women) and were referred for additional ultrasound and mammography examination, in 2020-2021 – 25,008 women (1.63%). 74.2% (1,205,094 women) had BI-RADS category 1 in 2018-2019 and 63.4% (971,754 patients) – during the pandemic. In 2018-2019 - 3,377 BC cases were detected (cancer detection rate was 2.0 per 1000 investigations). In 2020-2021 - 2,474 BC cases were identified (cancer detection rate 1.6 per 1000 investigations). Proportion of screen-detected cancers in stage 0-I was 45.1% in 2018-2019 and 47.5% in 2020-2021. During the pandemic, the number of participants who underwent BC screening significantly decreased (by 20.6% of the planned). The level of cancer detection decreased too (by 22.8%). There was an increase in patients requiring further examination (BI-RADS categories 4-5) and decrease the number women with BI-RADS 1. With an increase in indications for additional ultrasound and radiological examination, the number of revealed cancers reduced by 1.5 times (in 2018-2019, 14.5% patients with BI-RADS categories 4-5 had BC confirmed, in 2020-2021 – only 9.9%). Conclusions: BC screening has been significantly reduced during the COVID-19 pandemic. At the same time, attention should be paid to the increase in overdiagnosis of mammographic pathology, possibly due to an increase in the density of breast tissue on the background of nonspecific inflammation accompanied by lymphadenopathy. The impact of COVID-19 on BC is still unknown. Further research will be needed to confirm the link between COVID-19 and mammography picture and BC.
The implementation of fertility guidelines and impact on the rate of pre-therapy fertility risk discussions in pediatric oncology: A retrospective cohort study.
Authors: Cameron Crowell, Carol Digout, Rodrigo L. P. Romao, Annette Flanders, MaryJean Howitt, Craig Erker
Journal: Journal of Clinical Oncology (2022)

e22027 Background: Pediatric cancer patients undergoing treatment are often at risk for infertility or subfertility. Healthcare providers do not consistently deliver fertility information prior to therapy. Our objective was to assess if development and implementation of a fertility guideline improves the frequency of pre-treatment fertility discussions with pediatric cancer families. Methods: This retrospective cohort study analyzed all consecutively eligible patients over two time periods. The pre-guideline time period was 18 months prior to implementation and the post-guideline time period was 12 months after implementation. Guideline implementation included an education session with oncology staff. Eligible patients were &lt; 19 years old at cancer diagnosis and received chemotherapy and/or radiation therapy. Patients treated with palliative intent were excluded. Pre-guideline rate of pre-treatment fertility discussions was estimated at 40%. An estimated 40 participants in the post-guideline cohort can detect a 30% increase in fertility discussions with β 0.8 and α 0.05. Exploratory analysis assessed factors associated with the frequency of fertility risk discussions. Results: Ninety-five patients were included. Fifty-seven percent were &lt; 10, 26% were 10-15, and 17% were ≥ 16 years old. Pre- and post-guideline cohorts are compared in table. In the pre-guideline cohort, 41% of patients had a discussion about risks of fertility impairment documented, while post-guideline cohort had 49% documented ( p = 0.531). Exploratory assessment of combined cohorts found males (OR 0.2.7, 95% CI 0.1.2-6.3-0.87) and patients ≥ 10 years old (OR 5.0, CI 2.1-12.1) were more likely to receive fertility discussions prior to therapy. Radiation and cancer type did not influence whether fertility discussions occurred. Conclusions: Implementation of a fertility guideline did not increase discussions of fertility risk, and less than half of patients had a documented fertility risk discussion. Male patients and age ≥ 10 years old were more likely to have documented discussions about risks to future fertility. Effective strategies are needed to improve the rate of discussions regarding fertility risk to ensure families receive this information prior to therapy. [Table: see text]